MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-06-16 for MATTRESS THERAPY 42 X 84 X 6.5 9153651287 IES0080 manufactured by Invacare (ltd) Uk.
[5941849]
Provider states the mattress is sagging in the middle. Provider is aware to mail back the law labels for credit. Provider states the patient weight is 125 pounds.
Patient Sequence No: 1, Text Type: D, B5
[13489104]
A returned was issued and the product is awaiting receipt and/or evaluation. A follow up will be filed if/when any additional information is provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007582653-2015-00007 |
| MDR Report Key | 4846620 |
| Report Source | 08 |
| Date Received | 2015-06-16 |
| Date of Report | 2015-05-21 |
| Date of Event | 2015-05-19 |
| Date Mfgr Received | 2015-05-21 |
| Date Added to Maude | 2015-06-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KEVIN GUYTON |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVACARE (LTD) UK |
| Manufacturer Street | PENCOED TECHNOLOGY PARK PENCOED |
| Manufacturer City | BRIDGEND |
| Manufacturer Country | UK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MATTRESS THERAPY 42 X 84 X 6.5 9153651287 |
| Generic Name | MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE |
| Product Code | KIC |
| Date Received | 2015-06-16 |
| Model Number | IES0080 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE (LTD) UK |
| Manufacturer Address | PENCOED TECHNOLOGY PARK PENCOED BRIDGEND UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-06-16 |